WS®1442 in Slightly Overweight Subjects

Overweight Clinical Trial

Official title:

Investigation of Safety of WS®1442 in Slightly Overweight Subjects With Pilot Assessment of Pharmacodynamic Effects of WS®1442 on Endothelial Function

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00982501
• Other study ID #: 501004.01.103
• Status: Completed
• Phase: Phase 1
• First received: September 22, 2009
• Last updated: May 13, 2014
• Start date: June 2008
• Est. completion date: February 2011

Study information

• Verified date: May 2014
• Source: Dr. Willmar Schwabe GmbH & Co. KG
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Agency for Health and Food SafetyAustria: Ethikkommission
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to test:

1. Safety of 900 mg or 1800 mg of WS® 1442 per day in overweight subjects (BMI 25 to 29,9 kg/m²)

2. Pharmacodynamic effect of WS® 1442 on endothelial function versus nordic walking training in overweight subjects

Description:

60 overweight subjects with a BMI of 25 to 29,9 kg/m2 are to be included. The safety of 900 mg/1800 mg per day WS® 1442 is determined by adverse events, laboratory parameters, vital signs as well as by a treadmill test at the beginning and the end of the study. Endothelial function measured before and after two different training modalities is compared to that measured before and after intake of two different doses of WS® 1442.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: February 2011
• Est. primary completion date: September 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 45 Years to 75 Years

Eligibility

Inclusion Criteria:

• written informed consent

• male and female subjects aged 45-75 years

• untrained

• BMI between 25 and 29,9 kg/m²

• resting blood pressure in sitting position = 140/90 mmHg

• inconspicuous ergometry

Exclusion Criteria:

• pregnancy or breastfeeding

• any other current medication

• intake of other hawthorn preparation or dietary supplements with possible influence on the interpretation of study results

• any known diseases

• alcohol or drug abuse/addiction

• nicotine abuse

• any known hypersensitivity to any of the ingredients of the investigated drug

• inability or inadequate ability to write or speak German

• not-postmenopausal women: positive pregnancy test or unsafe contraception

• any urinary test finding requiring diagnostic assessment or treatment

• deformation of the 2nd to 5th finger of both hands preventing an adequate measurement of endothelial function

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator)

Related Conditions & MeSH terms

• Overweight

Intervention

Drug:
• WS® 1442 900 mg/d

• WS® 1442 1800 mg/d

Behavioral:
• Nordic walking training 2 x 30 min/week

• Nordic walking training 4x45 min/week

Locations

Country	Name	City	State
Austria	University Institute of Sports Medicine, Prevention and Rehabilitation, Paracelsus Medical University Salzburg	Salzburg

Sponsors (1)

Lead Sponsor	Collaborator
Dr. Willmar Schwabe GmbH & Co. KG

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse events		12 weeks	Yes
Primary	Lab parameters		12 weeks	Yes
Primary	Vital signs		12 weeks	Yes
Primary	Treadmill test including lactate measurement		12 weeks	Yes
Secondary	Endothelial function		12 weeks	No